CTRI Number |
CTRI/2019/08/020535 [Registered on: 02/08/2019] Trial Registered Prospectively |
Last Modified On: |
30/01/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
To evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck. |
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled parallel group study to evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
BIAG-CSP-031 version 1.0, 24 Jun 2019 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shubha Rani M |
Designation |
MD |
Affiliation |
Sri Krishna Sevashrama Hospital |
Address |
#49, 10th Main, 32 C Cross, 4th Block, Jayanagar, Bengaluru.
Bangalore KARNATAKA 560011 India |
Phone |
9449453674 |
Fax |
|
Email |
dr.shubharani111@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Shalini Dayananda |
Designation |
General Manager |
Affiliation |
BioAgile Therapeutics Private Limited |
Address |
#2/5, Dahlia Building, 3rd Floor,80 Feet Road, RMV 2nd Stage,Bangalore 560094, INDIA
Bangalore KARNATAKA 560094 India |
Phone |
08043754520 |
Fax |
|
Email |
pm@bioagiletherapeutics.com |
|
Details of Contact Person Public Query
|
Name |
Divya C |
Designation |
Director |
Affiliation |
BioAgile Therapeutics Private Limited |
Address |
#2/5, Dahlia Building, 3rd Floor,80 Feet Road, RMV 2nd Stage,Bangalore 560094, INDIA
Bangalore KARNATAKA 560094 India |
Phone |
9538961761 |
Fax |
|
Email |
divya@bioagiletherapeutics.com |
|
Source of Monetary or Material Support
|
ZeusHygia LifeSciences Private Ltd. Balanagar, Hyderabad, Telangana -500037 |
|
Primary Sponsor
|
Name |
ZeusHygia LifeSciences Private Ltd |
Address |
First Floor, Plot No.47, Raviraja Industries, TechnocratsTechnocrat Industrial Estate, Balanagar, Hyderabad, Telangana -500037
|
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Shubha Rani M |
Sri Krishna Sevashrama Hospital |
#49, 10th Main, 32 C Cross, 4th Block, Jayanagar, Bengaluru, Karnataka 560011 Bangalore KARNATAKA |
9449453674
dr.shubharani111@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ACE Independent Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Rheumatoid Arthritis (Knee, Hand and Neck) |
Patients |
(1) ICD-10 Condition: M249||Joint derangement, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
BioSOLVECurcuminTM |
To be taken 2 capsules of 500 mg to be taken in morning before breakfast and at night after dinner per a day fro 12 weeks |
Comparator Agent |
Placebo |
To be taken 2 capsules of 500 mg to be taken in morning before breakfast and at night after dinner per a day for 12 weeks |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients in the age group of 18-65 years, either male or female.
2.Diagnosis of RA according to the revised 2010 American College of Rheumatology (ACR) criteria (with RA functional class of II). Total number of the Swollen Joint Count (SJC) and Tender Joint Count (TJC) should be greater than 8.
3.Continuing or recurring pain (i.e joint pain daily, unless on pain medication).
4. Ability and willingness to participate in all components of the study
5. Patients who able to understand and sign written informed consent.
|
|
ExclusionCriteria |
Details |
1. Patients to whom one of following applies will be excluded: dysfunction of liver; severe cardiovascular, urinary, hematopoietic, or endocrine system disease; immunodeficiency; uncontrolled infection or active gastrointestinal tract disease; recent vaccination; gravida; women in lactation period or those recently intending to become pregnant; hypersensitivity to study product; treatment with any other disease-modifying anti-rheumatic drug (DMARD) or NSAIDS within 30 days before enrolment; history of alcohol abuse; history of hyperglycemia or motor coordination disorder; or participation in other clinical trials within 3 months before enrolment.
2.Patients with any surgical procedure, including bone or joint surgery or synovectomy within 12 weeks prior to screening.
3.Patients with significant systemic involvement of secondary RA (including diseases such as vasculitis, pulmonary fibrosis or Feltys syndrome), inflammatory joint disease other than RA (e.g. gout, psoriatic arthritis, seronegative spondyloarthropathy and Lyme disease)
4. Subjects with other systemic autoimmune disorder (e.g. systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap diseases
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To assess the comparative efficacy of investigational product BioSOLVECurcuminTM by the assessment of ACR-20, WOMAC scale and VAS in patients with active rheumatoid arthritis in knees, hands and neck. |
Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90) |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the safety of investigational product BioSOLVECurcuminTM in active rheumatoid arthritis patients. |
Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90) |
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
09/08/2019 |
Date of Study Completion (India) |
04/12/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not Applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disorder that primarily affects various body joints and causes progressive destruction of articular structures, particularly, the cartilage and bone. Notably, the joint destruction is a prominent feature of the disease that not only distinguishes RA from other arthritic diseases but also determines its outcome in the majority of individuals affected. The long-term prognosis of RA is poor with as much as 80% of patients affected becoming disabled after 20 years and a concomitant reduction in life expectancy by an average of 3–18 years. If the disease remains untreated, 20–30% of patients may become permanently work-disabled within 2–3 yr of diagnosis. Predictors of poor outcome for RA include relatively low functional disease activity scores early in the disease progression, lower socio-economic status and education level, strong family history of the disease, and early involvement of many joints. Thirty per cent of the patients with severe forms of the disease typically remain unresponsive to any classic treatment intervention. Nonetheless, patients with milder forms of the disease may derive some level of benefit from early diagnosis and treatment.
In view of the overwhelming literature and promise for the potential benefits of curcumin- induced chemoprevention and treatment of several human diseases, the current study is a pilot effort to assess the efficacy and safety of BioSOLVECurcuminTM in comparison with placebo for 12 weeks in patients with active rheumatoid arthritis in knees, hands and neck. BioSOLVECurcuminTM is a specially modified and formulated nutraceutical product with advantage of highly bioavailable curcumin for its intended pharmacological effect. The main aim of the study is to investigate the effect of BioSOLVECurcuminTMin patients with active Rheumatoid Arthritis (RA) using subjective questionnaires as the evaluation parameters as well as assessment of the safety of the study product. |